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Does low-dose botulinum toxin help the recovery of arm function when given early after stroke ? A phase II randomized controlled pilot study to estimate effect size

Spasticity after stroke may be associated with worse functional
outcome. Our study aim is to establish whether a low dose of botulinum toxin,
given early post stroke before clinically evident spasticity warrants treatment,
will improve recovery of arm function. DESIGN: A double-blind randomized
placebo-controlled trial. SETTING: An acute stroke unit. SUBJECTS: Individuals
recruited within three weeks of stroke onset with severe arm function deficits.
INTERVENTIONS: Injections of quarter and half standard dose botulinum toxin A to
the upper limb, with a control of normal saline injections. MAIN MEASURES: Arm
function, active and passive movement, and spasticity at elbow and wrist were
recorded at baseline, and at 4, 8, 12 and 20 weeks post intervention. A
pre-planned subgroup analysis included only subjects with no arm function at
baseline (Action Research Arm Test score = 0). RESULTS: Thirty subjects were
recruited, and 21 completed all assessments. Arm function scores improved in all
three groups between baseline and week 20. There was no benefit for active
treatment over control in the whole group analysis. In the subgroup analysis the
active groups improved when compared with the control group and effect sizes for
improvement in this subgroup were 0.6 and 0.5 for the quarter dose and half dose
groups respectively. CONCLUSIONS: Individuals with no arm function within three
weeks of stroke may benefit functionally from botulinum toxin. Using the effect
size of 0.5, further studies would need a minimum of 101 participants in each
group to confirm this finding.

Langue : ANGLAIS

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